A.09.03_W81K00-18-R-0035-0001.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: RALPH E. HOUSEMAN

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

1. The purpose of this amendment is to delete in its entirity the Statment of Objectives (SOO) and partially revise the lanuage in Addendum 52.212-1 & 52.212-2 as posted in RFQ W81K00-18-R-0035 and replace it w ith the follow ing SOO and Addendum(s) 52.212-1 & 52.212-2.

2. See Summary of Changes

All other Terms and Conditions Remain Unchanged

1. CONTRACT ID CODE PAGE OF PAGES

1 9

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 22-May-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W81K0018R0035

X 9B. DATED (SEE ITEM 11)

11-May-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

22-May-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0018R0035

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

STATEMENT OF OBJECTIVES (SOO)

The Regional Health Contracting Office - Central has a requirement for various prosthetic-orthotic supplies.

When ordered, the prosthetic supplies item must pass a Technical Inspection performed by the regional healthcare facility’s Chief of Prosthetic prior to being accepted for use by the Government. The date/time of the product and case number will be provided to the vendor upon placement of an order. An order number shall be provided to the vendor by the Ordering Officer.

The government intends to award multiple Blanket Purchase Agreements (BPA) to offers that are determined technically acceptable and offer a fair and reasonable price. BPA(s) will be established under Federal Acquisition Regulation (FAR) Part 12 and 13. BPA(s) issued as a result of this solicitation will have a single bulk call limit of up to $350,000.00 for a 3 months delivery period, with a maximum overall BPA limit of $7,000,000.00.

BPA calls/orders will be based on patient need and physician preference. The Medical Treatment Facility (MTF) will schedule deliveries against the bulk call as needed based on a case by case basis. Offerors are reminded that, in the event they receive a BPA, calls/orders are not guaranteed. Funds are not obligated on the BPA, but only on any issued calls/orders.

The anticipated period of performance is 1 July 2018 through 30 June 2023. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 -Prosthetic Appliance and Supplies Manufacturing, Size Standard: 750. This procurement is being conducted as a full and open competition.

Medical Treatment Facilities requiring prosthetic-orthotic supplies are listed below:

San Antonio Military Medical Center, Fort Sam Houston, TX

NOTE 1: The terms “offer” and “offeror” should be interpreted to mean the same as “quote” and “quoter” wherever they appear in the solicitation.

NOTE 2: A price list template is included as Attachment II. Offerors may submit their own format, but should include as a minimum the headings/categories listed on the template.

SCOPE

The following points represent the Government’s requirements for the prosthetic supplies. Designed to restore function by replacing or reinforcing a damaged structure. The government is seeking vendors that are capable of providing prosthetic-orthotic supplies externally fitted to patients for one or more of the following areas;

1. SALIENT CHARACTERISTICS for externally powered prosthetic elbows, hands, waterproof microprocessor prosthetic knees, and powered ankles.

a. Externally Powered Hands

Hands must be capable of myoelectric or switch control

Hands must have individual articulations of each finger and thumb

Individual digits must be clinician replaceable

Each digit must have individual motor driven control

Hand must be available in multiple sizes

Hands must be programmable in up to 24 grip patterns.

Hands must be capable of gesture control

Touch screen capable fingertips must be available

Powered thumb positioning must be available

b. Externally Powered Elbows

• Elbow must integrate an axon bus controller

• Elbow must be capable of a 0.5 second extension to flexion range

• Elbow must be available with a black forearm shell and cover

• Elbow must be capable of independent adjustment of the motor speed at the terminal device, wrist and elbow independently

• Elbow must provide a minimum of 3 switching strategies to toggle between motors Must provide an externally powered hand with an auto grasp feature

c. Microprocessor Knees (MPK)

MPK must have a manual lock option for full knee extension MPK must use a weight activated stance control MPK will be Bluetooth programmable MPK must have 275lb weight capability MPK must have no more than a MPK must be both PC and Apple IOS compatible for Bluetooth connection and programming MPK incorporates magnetorheological (MR) fluid and rotary blades to control knee flexion resistance.

Must provide an MPK option for both powered knee extension and flexion MPK will incorporate load cells that sample force measurements at a rate of at least 1000 times per second MPK will have no more than a 9 ¼” build height

d. Waterproof Microprocessor Knees (MPK)

• MPK must be ISO tested for submersion in one meter of water

• MPK have at least 5 programmable function modes

• MPK will have a stair mode to allow knee flexion with weight applied

• MPK will eliminate flexion and extension resistance when in a seated flexion

• MPK must be capable of locking in variable ranges of knee flexion when weight is applied.

• MPK must be capable of programming a safe mode that initiates in the event of electronic malfunction MPK utilizes hydraulic fluid to control knee flexion resistance.

• MPK incorporates a magnetic charger head with LED charge level indicators

• MPK must provide vibration and audible signals for battery life and malfunction indication

e. Externally Powered Ankles

• Ankle must provide proportional powered plantar flexion across all walking speeds

• Ankle must provide at least 22 degrees of plantarflexion range

• Ankle must move into passive plantarflexion when user is seated

• Ankle adjustments must be programmable with a clinician interface

• Ankle must self-adjust for toe clearance on stairs

• Ankle must adjust to heel height changes by the end user

2. SPECIFIC REQUIREMENTS: The requirements for the prosthetic-orthotic patient casting, fabrication, and fitting supplies item are:

a. Patient Casting Must provide a full selection of plaster bandage in rigid, elastic and splint configurations Must provide fiberglass bandage in roll form with multiple colors Must provide duplicating materials for reproduction of prosthetic sockets

b. Prosthetic-Orthotic Fabrication Supplies

Must have acrylic resin compatible with all standard laminating fabrics Will provide epoxy resin for use with carbon fiber braid and sheet materials.

Will provide carbon fiber laminating materials for use in prosthetic and orthotic fabrication procedures Must provide full range of available thermoplastic materials to include those for drape and blister forming.

Must provide standard laminating stockinettes in all sizes and materials to include nyglass, fiberglass, nylon, cotton.

Will provide all hand and power tools necessary for fabrication of prosthetic orthotic devices

c. Fitting Supplies

Will provide a full range of silicone gel liners, elastomeric liners and fitting socks Will provide a full range of locking mechanisms to include ratchet type, smooth pin, internal and external locks.

Will provide suspension sleeves in silicone, TPE, elastomeric gel in all sizes and available colors Will provide mechanical knees with friction, hydraulic control, pneumatic for walking and running activities.

Will provide feet with microprocessor ankles, dynamic response categories, carbon fiber and fiberglass design for all levels of activity.

3. SPECIFIC REQUIREMENTS: The requirements for silicone cosmetic restorations and custom prosthetic interfaces.

Must be able to provide custom silicone cosmetic restorations for upper and lower limb amputees.

Must be able to perform custom color skin matching Must be able to match the pertinent skin and shape characteristics to the sound limb or facsimile Must be able to create custom inner interfaces for both lower and upper extremity prosthetics Must have the ability to incorporate myoelectric components and wiring within the interface Must be able to provide interfaces with variable densities of silicone Must be able to incorporate reinforced regions as specified and determine attachment sites Must have personnel available within 3 working days of request for custom consultation.

Must be capable of providing diagnostic inner liners within 5 working days

4. PROSTHETIC-ORTHOTIC SUPPLIES LIST

Attachment I – Cross Reference Product Matrix includes a sample listing of prosthetic-orthotic supplies;

fabrication supplies and cosmetic restorations supplies required for the prosthetic listed in paragraphs 1, 2 & 3 of this solicitation. Vendors are encouraged to provide a comprehensive price list which includes all offered prosthetic supplies, fabrication, cosmetic and supply items as it relates to this requirement.

Attachment II provides a template for vendor product and price listing.

CROSS REFERENCE PRODUCE MATRIX

GOVERNMENT'S SAMPLE

PROSTHETIC-ORTHOTIC SUPPLIES

LIST

VENDOR OFFERED

PROSTHETIC-ORTHOTIC

SUPPLIES

PROSTHETIC

Category

Discounted

BPA

Price

DESCRIPTION DESCRIPTION

ICEROSS UPPER X 16

CLUTCH ICE LOCK 4H 214

ICEROSS SEAL-IN SOCKS, SIZE 13, ICEROSS

FEMALE PYR TUBE CLAMP TITANIUM

DISTAL CUP DERMO SZ 26

CAR ADAPTER CABLE 12V

GENIUM KNEE W/PYLON

ERGO ARM ELECTRONIC PLUS

PROSTHETIC KNEE SYSTEM

GENIUM X3 3B5-2=ST THREADED

CUSTOM ELBOW SOCKET IN NOT

CON/ATYP

BELOW/ABOVE ELBOW LOCK MECH

BELT WAIST & SOCKS CUSTOM L599

INTL CUSTOM CONG/LATYP INSERT

REPLACEMENT BP SOCKET

3PLY SOFT SOCK REG XTRA SHORT

1SP3RGXS 19

50# BAG MOULDING PLASTER ORDER 9 OR

1/2 IN PROFLEX W/SILICONE 24 X 48

TALC BABY POWDER 51394 40

LYN VALVE BK2 - METRIC

FREESTYLE FOOT ASSEMBLY

STANDARD WRIST ROTATOR (BLACK)

PROPLUS RIGHT

SILICONE SEAL

SHOE HORN

LINER SEAL

FOOT COVER

PROSTHETIC SOCKS

ADULT KNEE IMMOBILIZER

FOOT SHELL

Attachment II - Provides a template for vendor product and price listing.

PROSTHETIC-ORTHOTIC SUPPLIES LIST

Part Number Description Orthopedic Category

List Price Discount Percentage

BPA

Price

The following full text addendums have been revise: See BLUE text

ADDENDUM TO 52.212-1

Volume I – Technical Capability

Factor 1 - Technical Capability - The technical offer shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical aspects of the Government’s requirement. Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications of parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Insufficient explanations may result in your offer receiving an UNACCEPTABLE rating.

Sub-factor 1A – Specific Requirements – Offerors shall provide a detailed explanation as to how their prosthetic products meet each item listed in paragraph 1, subparagraph (a through e) of the "SALIENT CHARACTERISTICS" and each item listed in paragraph(s) 2 and 3 of the “SPECIFIC REQUIREMENTS” section of this solicitation.

Sub-factor 1B – Prosthetic Supplies Category Identification – Offerors shall identify the category of prosthetic supplies that can be supported by the items provided on their price list.

Offerors must use at least one of the prosthetic categories listed in paragraph 4 of the Statement of Objectives. Offerors may identify more than one prosthetic category and may include other prosthetic categories not listed in paragraph 4, so long as at least one of the listed categories found in paragraphs 1, 2 & 3 is used. The category or categories must be stated on the price list.

Offerors may use the template provided in attachment II or similar format when completing submittals for this sub- factor.

Sub-factor 1C – Delivery Terms – Offeror must meet the 48 hour prosthetic availability lead time along with providing product ordering procedures and delivery lead time for routine orders in order to be deemed acceptable for this subfactor.

Sub-factor 1D – Cross Reference Product Matrix - Offerors shall complete Attachment II or a similar format, by cross- referencing comparable items offered against the list of items provided in Attachment I. The offeror shall specify the category of prosthetics covered under their cross reference matrix list along with the item’s associated discounted price. A minimum of three items shall be cross referenced.

Volume II - Pricing: Remains Unchanged

Volume III - Administrative: Remains Unchanged

END OF ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-2

Evaluation Process.

The Government anticipates awarding multiple blanket purchasing agreements to responsible vendor(s) whose offer meets or exceeds the minimum technical requirements of the solicitation and provides fair and reasonable pricing. Awards will be made based on the prosthetic categories listed in paragraph 4 of the Statement of Objectives. Offerors must provide a comprehensive price list for prosthetic-orthotic supplies for at least one of the prosthetic categories stated in paragraph 4 of the SOO in order to eligible for award. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

Factor 1 – Technical Capability

Factor 1 - Technical Capability - Technical capability ratings reflect the Government’s confidence in the offeror’s ability, as demonstrated in its written technical proposal, to meet the requirements stated in the solicitation. The Government will make an independent judgment of each sub-factor and of the technical acceptability on offered products. Each subfactor, and the overall factor, will be evaluated using Table 1 below:

Sub-factor 1A – Specific Requirements – Offeror must meet or exceed each requirement listed in paragraph 2 & 3 of the Statement of Objectives in order to be acceptable in this sub- factor. Acceptability will be determined by whether or not the offeror has provided an adequate response or explanation for each requirement listed.

Sub-factor 1B – Prosthetic Supplies Category Identification –Offerors must identify at least one of the prosthetic categories listed in paragraph 4 of the Statement of Objectives when submitting their price list. The category or categories must be stated on the price list in order to be deemed acceptable under this sub- factor.

Sub-factor 1C – Delivery Terms – Offeror must meet the 48 hour prosthetic availability lead time along with providing product ordering procedures and delivery lead time for routine orders in order to be deemed acceptable for this subfactor.

Sub-factor 1D – Cross Reference Product Matrix - Offerors must provide the completed Attachment I which includes a minimum of three cross referenced items in order to be deemed acceptable for this sub- factor

Technical Evaluation Criteria: Remains Unchanged Factor 2 – Price: Remaing Unchanged

END OF ADDDENDUM TO 52.212-2

SECTION SF 1449 - CONTINUATION SHEET

The following have been deleted:

(End of Summary of Changes)